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EMG Biofeedback Treatment for Chronic Low Back Pain, Cancer Pain and Migraines

CompletedNot applicableNCT04607460
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The purpose of this pilot efficacy study is to examine the effects of EMG-biofeedback (EMG-BF) on pain-related outcomes in Chronic Low Back Pain (CLBP) patients, Recent mastectomy and lumpectomy patients, and patients with episodic migraine. EMG-BF facilitates neuromuscular retraining and muscle relaxation by using audio and visual stimuli using an EMG surface electrode-based biosensor and a software installed on a tablet or smart phone. For this pilot efficacy study, we will recruit 125 patients with chronic low back pain, 125 patients who are expected to undergo mastectomy and 80 patients with episodic migraine. Participants will be randomly assigned to either the JOGO Digital Therapeutics EMG Biofeedback device or treatment as usual control group. Patients assigned to the intervention group will be asked to complete self-report questionnaires assessing demographics, pain intensity, negative affect, physical function, pain catastrophizing and sleep, will undergo QST and will be asked to wear Actiwatches to keep track of health behaviors, prior to and after completing the intervention. The intervention consists of weekly sessions during which participants will be instructed on how to use the device by a trained biofeedback instructor. Patients in the control group will undergo sensory testing procedures at baseline and after treatment period but will receive no active treatment. The aims of this study are to examine the impact of EMG-BF on pain and QST and the impact of EMG-BF on psychosocial function. We hypothesize that patients that will undergo the EMG-BF will demonstrate reductions in pain, physical functioning, sleep, pain catastrophizing, anxiety and depression.

Study details

Official title
Biofeedback EMG Alternative Therapy for Chronic Low Back Pain and Chronic Cancer Pain (BEAT-Pain): A Pilot Efficacy Study
Interventions
  • Device: JOGO Digital Therapeutics EMG Biofeedback for Lower Back Pain
  • Device: JOGO Digital Therapeutics EMG Biofeedback for Persistent Post Mastectomy Pain
  • Device: JOGO Digital Therapeutics EMG Biofeedback for Migraine
Sponsor
Brigham and Women's Hospital
Start date
2020-12-03
Primary completion
2023-12-30
Sex
All
Age range
from 18 Years to 65 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Low Back Pain Inclusion Criteria: * Age 18-65 years old; * Chronic Low Back Pain as seen on medical history for at least 6 months but no longer than 10 years; * A minimum score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions; * are able to speak and understand English, and (6) have access to a computer or tablet at home and have an email address. Exclusion Criteria: * Lower back surgery within previous twelve (12) months; * Comorbid chronic pain condition that is rated by the subject as more painful than CLBP * Pain condition requiring urgent surgery; * Females who are pregnant; * Subjects with a severe visual or hearing impairment; * Evidence of non-mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder incl. acute osteomyelitis or acute bone disease; * Subjects currently under active cancer treatment (chemo, infusion, ongoing radiation); * Implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator); * Medical condition known to influence QST or participation in the EMG intervention * (e.g. HIV, peripheral neuropathy, Raynaud's syndrome); * Present or past serious psychiatric condition (e.g. Schizophrenia, delusional disorder, * psychotic disorder, or dissociative disorder) or any psychiatric condition that required hospitalization the past year and that would be judged to interfere with study participation. * Active addiction disorder, such as cocaine or IV heroin use, that would interfere with * study participation, * Diagnosis of mild cognitive impairment or dementia * Significant medical abnormalities or conditions that in the opinion of the Practitioner * would interfere either with the ability to complete the study or the evaluation of the investigational device's safety and efficacy. * Recent history of a significant medical-surgical intervention that in the judgment of the * Practitioner would interfere either with the ability to complete the study or the evaluation of the investigative device's safety and efficacy. * Known allergic skin reaction to tapes and plasters. * Subject who is currently enrolled in an investigational drug or device study. Chronic Cancer Pain Inclusion criteria: * Female * Aged 18-65 years old * Recent bodily pain complaints with a minimum score of \>1 on pain visual analog scale (VAS) at the start of experimental sessions; * Scheduled for breast biopsy * Willingness to undergo psychophysical and psych…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04607460